Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
This is a fully onsite role based at our customer’s site in Collegeville, PA. We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate.
Must be legally authorized to work in the United States without sponsorship.
Must be able to pass a comprehensive background check, which includes a drug screening.
At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.
Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our customers to make the world healthier, safer, and cleaner.
Our Laboratories Functional Service Partnership (FSP) team plays a direct role in advancing drug development by creating sustained groups of talent within our customers’ organizations to provide long-term support. Through this collaborative approach, our professionals bring their commitment to excellence, industry knowledge, and operational strength directly into customer environments, helping to enhance capabilities and advance the delivery of life-changing therapies.
Key responsibilities:
•Responsible for clinical sample testing for anti-drug antibody (ADA) and neutralizing antibody (NAb) clinical studies in a GCP compliant laboratory setting.
•Use Watson LIMS to track samples, import and analyze data
•Maintain routine lab operations/equipment and safe work conditions
•Use Hamilton Liquid Handler for high throughput analysis
•Follow SOPs, methods and checklists and document experiments in Signals electronic laboratory notebook (eLNB) in accordance with GCP guidelines
•Perform experimental work using human serum samples in accordance with Human Biological Sample Management (HBSM), safety and data integrity guidelines.
Education and Experience:
Bachelor's degree or equivalent in Biology, Biochemistry, Immunology or related discipline
AND 2+ years of experience OR MS degree in relevant scientific degree
Hands-on experience or theoretical understanding of clinical plate-based immunoassay validation and study support using various immunoassay platforms (MSD /Singulex) to support immunogenicity (ADA and NAb) endpoints.
Preferred: At least 1 year experience working in a GCP laboratory, Direct ADA experience, Previous experience working with Watson LIMS.
Knowledge, Skills and Abilities:
•Hands-on experience or theoretical understanding of clinical plate-based immunoassay validation and study support using various immunoassay platforms (MSD /Singulex) to support immunogenicity (ADA and NAb) endpoints.
•Maintains a disciplined approach, ensuring a relentless focus on quality, compliance, scientific rigor and operational excellence.
•Attention to detail and good communication and documentation skills will be expected.
Working Environment:
Below is listed the working environment/requirements for this role:
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to work upright and stationary and/or standing for typical working hours.
Able to lift and move objects up to 25 pounds
Able to work in non-traditional work environments.
Able to use and learn standard office equipment and technology with
proficiency.
May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!